Completion of full documentation

:shades:

It is hump day and could not think of anything better than requesting some thoughts and directions on my weekly topic hunt.

We have several documents that are completed in our plant on a daily basis with requirements for checks to be completed every 30- 60 minutes.  Our procedure for completing monitoring check sheets state that no blank space are permitted and if the line is down when a check is completed they write in NR (not running).  This is all well and good during regular production.

However, our cleaning cycle is every 21 days.  A shift may come in run for a couple of hours then the line go down for the major clean up that lasts 24 hours as the entire facility is cleaned.  Currently they are still required to fill in the 30-60 minute checks every hour if a document was started on shift before the line goes down.  Is there any audit requirement that this must be done?

What we are discussing to do is add to the procedure that if the line goes down for clean-up that monitors can write in the next column that "Line down for clean-up at XX:XX" and not be required to fill in the rest of the document.

Would this be permissible with most audits and regulatory inspections if this were part of the procedure?

Thanks in advance.

Hi Jim E ,

Yes you can as far you have a documentation indicating the when the cleaning started and when it is finished and when the line launched again ( start up )

for example if the line is running for two hours in shift A ,then stopped for cleaning so no need to inspect every 30 /60 min. as far the line is in cleaning ,shut down or break down , you have to indicate when it is stopped and when it is launched again .

you should consider the nature of the line and process , in some cases you have to monitor some parameters even during stoppage so risk assessment should be done before doing this , but for cleaning it is OK since for sure all the line is stopped.

BR,

Ehab

Yes, but on the next line after line down - add in Line back in service at such and such a time.